From: Jo Anna Shimek <joanna.shimek**At_Symbol_Here**GMAIL.COM>
Subject: Re: [DCHAS-L] Testing of water contaminated area
Date: January 23, 2013 12:53:54 PM EST
Reply-To: DCHAS-L <DCHAS-L**At_Symbol_Here**MED.CORNELL.EDU>
Message-ID: <846069202.196853.1358957129468.JavaMail.root**At_Symbol_Here**>

Your Microbiology Group should have the standards to meet. These standards are likely following Good Laboratory Practice or Good Manufacturing Practice standards. If this is a production facility and the FDA has approved the production of goods then the application submitted to the FDA will have the standards stated in the submission. I'd start with your Microbiology Group. They should know what standards they are testing against..
I'll be interested in any other comments you get.
Jo Anna Shimek PhD, CIH, CSP
Clinical Assistant Professor
Indiana University

On Wed, Jan 23, 2013 at 11:05 AM, George D. McCallion <medchem**At_Symbol_Here**> wrote:

Dear DCHAS Members:

In our facility we have a high potency suite which exits into a misting room (water followed by forced air) for decontamination. From this room, we exit into a degowning room prior to exiting onto the common area. An incident occurred the other day whereby water had penetrated from the ceiling into this degowning area. The room was cleaned by housekeeping.

The problem I have is potential microbial growth. We have our Microbiology Group running the tests for this. From their wording (I am process chemist by trade) the following tests are performed:

Side wall samples and a floor samples were taken using a Rodac plate; air samples taken using a TSA plate, and take a non-viable particle count for particles >0.5um.

Plates are incubated at 22.5degC for 24-72 hours and then 32.5degC for 48-72 hours.

All bacteria/yeasts/molds are macroscopically identified and performed with gram stain and biochemical tests if necessary.

Would anyone know of documentation that exists that can provide specified limits for rooms such as this?

Any help would be greatly appreciated.




George D. McCallion

QA Reviewer, Quality and Compliance

QS Pharma, LLC

3 Chelsea Parkway, Suite 305

Boothwyn, PA 19061

Mobile: 610.888.2436

Office: 610.485.4270, ext. 245


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